Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-02-21 @ 9:34 AM
Study NCT ID:
NCT03030105
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2017-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Effects of BPN14770 on Scopolamine-induced Cognitive Impairment in Healthy Volunteers
Sponsor:
Tetra Discovery Partners
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Single-dose, 6-Period Crossover Study to Evaluate the Effects of BPN14770 on Scopolamine-induced Cognitive Impairment in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1, randomized, double-blind, placebo-controlled, 6-period crossover study to evaluate the effects of BPN14770 10 mg and 50 mg in reversing scopolamine-induced cognitive impairment in healthy volunteers. A positive control, donepezil 10 mg, will be included, and additivity of BPN14770 50 mg to donepezil 10 mg in reversing scopolamine effects will also be evaluated.
Detailed Description:
A total of 38 subjects will be enrolled into the study. The study duration will be up to 12 weeks with 6 weeks of single-dose Treatment Visits. The study will consist of a Screening Visit (up to 28 days prior to first study drug administration), six inpatient Treatment Visits (Periods 1 through 6), and a Follow-Up/Early Termination Visit (7-10 days after the last dose of study medication). An additional study visit may be necessary to complete the required cognitive test familiarization if not completed during the Screening Visit. Each Treatment Visit will occur approximately one week apart, allowing a 6 to 8 day washout period.
Subjects will be randomized to 1 of 6 treatment sequences based on a computer-generated randomization schedule. Subjects will receive all 6 treatments as specified by the treatment sequence according to a 6 × 6 Williams Latin square design. The following treatments will be administered:
A. Scopolamine placebo + BPN14770 placebo + donepezil placebo
B. Scopolamine 0.5 mg + BPN14770 placebo + donepezil placebo
C. Scopolamine 0.5 mg + BPN14770 10 mg + donepezil placebo
D. Scopolamine 0.5 mg + BPN14770 50 mg + donepezil placebo
E. Scopolamine 0.5 mg + donepezil 10 mg +BPN14770 placebo
F. Scopolamine 0.5 mg + BPN14770 50 mg + donepezil 10 mg
During each of the Treatment Visits (Periods 1 through 6), subjects will be admitted to the Clinical Research Unit (CRU) the day prior to each study drug administration (Day -1) and discharged the day after study drug administration (Day 2). On the morning of study drug administration (Day 1), subjects will be given study drug (BPN14770, donepezil, or placebo) with 240mL of room temperature water 2 hours prior to the scopolamine or scopolamine placebo sc injection. The timing for study drug administration will be referred to as t-2 (Hour -2). Breakfast should be available approximately 30 minutes following the morning drug administration. Two hours after study drug administration, the scopolamine or scopolamine placebo sc injection will be administered. The time at which the scopolamine or scopolamine placebo sc injection is administered will be referred to as t0 (Hour 0).
Cognitive testing will be performed 30 minutes prior to treatment with scopolamine injection and at hours 1, 2, 3, 4, and 6 post-scopolamine injection.
PK samples will be collected during the treatment period to confirm study drug is present.
Safety assessments throughout the study will include physical exams, ECGs, vital signs, chemistry, hematology, and urinalysis.
Subjects will be randomized to 1 of 6 treatment sequences based on a computer-generated randomization schedule. Subjects will receive all 6 treatments as specified by the treatment sequence according to a 6 × 6 Williams Latin square design. The following treatments will be administered:
A. Scopolamine placebo + BPN14770 placebo + donepezil placebo
B. Scopolamine 0.5 mg + BPN14770 placebo + donepezil placebo
C. Scopolamine 0.5 mg + BPN14770 10 mg + donepezil placebo
D. Scopolamine 0.5 mg + BPN14770 50 mg + donepezil placebo
E. Scopolamine 0.5 mg + donepezil 10 mg +BPN14770 placebo
F. Scopolamine 0.5 mg + BPN14770 50 mg + donepezil 10 mg
During each of the Treatment Visits (Periods 1 through 6), subjects will be admitted to the Clinical Research Unit (CRU) the day prior to each study drug administration (Day -1) and discharged the day after study drug administration (Day 2). On the morning of study drug administration (Day 1), subjects will be given study drug (BPN14770, donepezil, or placebo) with 240mL of room temperature water 2 hours prior to the scopolamine or scopolamine placebo sc injection. The timing for study drug administration will be referred to as t-2 (Hour -2). Breakfast should be available approximately 30 minutes following the morning drug administration. Two hours after study drug administration, the scopolamine or scopolamine placebo sc injection will be administered. The time at which the scopolamine or scopolamine placebo sc injection is administered will be referred to as t0 (Hour 0).
Cognitive testing will be performed 30 minutes prior to treatment with scopolamine injection and at hours 1, 2, 3, 4, and 6 post-scopolamine injection.
PK samples will be collected during the treatment period to confirm study drug is present.
Safety assessments throughout the study will include physical exams, ECGs, vital signs, chemistry, hematology, and urinalysis.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: